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A positive recommendation from an FDA Advisory Committee has set Novartis’ Entresto (sacubitril/valsartan) on track to become the first drug to be approved for the treatment of heart failure with preserved ejection fraction (HFpEF). The potential label expansion could prove to be extremely lucrative for Novartis, providing the company with a first-mover advantage in this […]
NovoNordisk’s Rybelsus a game changer in T2D but may face a tough road ahead as it strides into Alzheimer’s space
NovoNordisk’s decision to investigate its recently launched Type 2 Diabetes (T2D) drug Rybelsus (semaglutide) in a pivotal Phase IIIa study of patients with early Alzheimer‘s disease may allow the company to secure its position in yet another lucrative market. However, while this drug will benefit from being the first-to-market oral GLP-1RA in T2D space and capture a […]
Renal denervation market demonstrates tremendous opportunity following FDA breakthrough device designation
SoniVie and ReCor Medical both recently received US Food and Drug Administration (FDA) breakthrough device designation for their TIVUS and Paradise renal denervation systems. With few manufacturers in the field and a market opportunity of almost 10 million hypertensive patients each year, the breakthrough designation puts ReCor Medical and SoniVie far ahead of larger manufacturers […]
COVID-19 has left a third of areas in America with limited ICU capacity
The growing rate of new COVID-19 cases indicates the US is facing a major crisis of hospital shortages not yet seen in this pandemic, and there is an expected near-doubling of hospitalizations and intensive care unit (ICU) admissions before year’s end, says GlobalData, a leading data and analytics company. Topias Lemetyinen, Pharma Analyst at GlobalData, […]
COVID-19 deals boost South Korea’s pharmaceutical industry growth
South Korea’s pharmaceutical sector is becoming increasingly innovative and attractive to foreign investment only 18 months into the government’s $1.7bn five-year biotech plan. The country’s pharmaceutical industry is now poised to grow further due to its preparations to manufacture large amounts of COVID-19 vaccines for domestic and foreign markets, says GlobalData, a leading data and […]
Telemedicine market growth in India to aid in success of national digital health plans, says GlobalData
The COVID-19 pandemic and the subsequent lockdown measures have led to the widespread adoption of telemedicine in India. Against this backdrop, the growing market can expand as well as enhance healthcare access and aid in the success of the country’s national digital health plans, says GlobalData, a leading data and analytics company. India’s foray into […]
Novartis embracing digital tools will help strengthen its position in key ophthalmology indications
Novartis recently engaged in a flurry of collaborative agreements in the ophthalmology field and the scope of these collaborations will help the company to pull ahead of its competitors in a broad spectrum of activities ranging from research and development (R&D) to product positioning to enhancement of patient journey, says GlobalData, a leading data and […]
Roche’s Ocrevus set to top $7.6bn in sales by 2028, backed by new dosing approval in the MS market
Following the news that the US Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for Roche’s Ocrevus (ocrelizumab) in patients with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS); Sarah Elsayed, MBA, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view: “Ocrevus boasts a superior pharmacological profile in the MS market due to its high efficacy, good tolerability and convenient six-month dosing regimen via intravenous infusion (IV). The new FDA approval will further improve […]
JDRF’s T1Detect population screening could revolutionize type 1 diabetes awareness and management
Juvenile Diabetes Research Foundation (JDRF) recently announced the launch of its ground-breaking screening initiative for type 1 diabetes (T1D), T1Detect, which aims to make early detection of T1D easier and more accessible to the broader population. This initiative will revolutionize awareness and management of the disease going forward as it will open up the market for preventative therapeutics and other disease-modifying therapies, says GlobalData, a leading data and analytics company. Samisha Khangaonkar, Pharma Analyst at GlobalData, comments: “Approximately 85% […]
Established players in Japan’s immunology market dominate branded digital marketing space, finds GlobalData
The Japanese immunology market is highly competitive with many innovator products available for rheumatoid arthritis (RA), psoriasis (PsO), psoriatic arthritis (PsA), inflammatory bowel disease (IBD) comprising ulcerative colitis (UC) and Crohn’s disease (CD), and ankylosing spondylitis (AS) indications. Across these indications, the branded support available for initially approved therapies dominate the digital marketing space compared […]
COVID-19 expedites India’s focus on innovation within pharma, says GlobalData
The COVID-19 pandemic has pushed India to expedite focus on pharma research and development (R&D) to become more independent. The hope of getting indigenous COVID-19 vaccines has boosted the government’s confidence towards indigenous research and development and this momentum should continue, says GlobalData, a leading data analytics and research company. India is expected to unveil a […]
AbbVie’s Rinvoq tops defending champion Dupixent in atopic dermatitis
The recently demonstrated superiority of AbbVie’s Rinvoq (upadacitinib) versus Regeneron and Sanofi’s Dupixent (dupilumab) across primary and all secondary endpoints in the Phase IIIb Heads Up study may well showcase its potential to usurp Dupixent as the gold standard of atopic dermatitis (AD) therapy, but it is the speed of which the efficacy became evident in patients that shows the drug’s real promise, says GlobalData, a leading data and […]
New therapies to overcome the unmet needs in hepatocellular carcinoma
The overall level of unmet need in hepatocellular carcinoma (HCC) is high due to its severity and low survival. However, the needs will soon be relatively well met, as many new therapies entering the market have different mechanisms of action and are aiming to meet needs in different treatment settings, says GlobalData, a leading data […]
UniQure’s EtranaDez set to become first gene therapy approved for hemophilia B, disrupting mostly stagnant market
With a 2021 Food and Drug Administration (FDA) submission now on the cards, following impressive data from its pivotal trial HOPE-B, uniQure’s etranacogene dezaprvovec (EtranaDez) is now set to become a first-in-class gene therapy agent with a label in hemophilia B. This will allow uniQure to tap into a market worth $1.3bn per year and […]
Doubts remain over Arcturus’s one-shot COVID-19 vaccine’s potential to match other leading candidate
There are eight mRNA COVID-19 vaccine candidates currently in Phase II or Phase III clinical trials. These vaccines are faster to develop than traditional vaccine formulations, as they use only the genetic sequence of the virus. Leading COVID-19 mRNA vaccine candidates reported greater than 90% efficacy, which raises concerns if other candidates in earlier stages […]
US cannot wait on vaccines to control COVID-19
Following the news that the US Food and Drug Administration (FDA) has recommended emergency approval for the Pfizer-BioNTech COVID-19 vaccine and that the US has reported its highest one-day COVID-19 death tally; Kasey Fu, Director of Epidemiology at GlobalData, a leading data and analytics company, offers her view: “News that the US has hit another […]
Slovakia’s national COVID-19 testing program was only a temporary solution
Following Slovakia’s national testing program from 31 October – 1 November, where two-thirds of the population were tested and the number of new daily cases dropped substantially, Slovakia was applauded for its efforts and held up as a possible solution to other European countries, says GlobalData, a leading data and analytics company. Katie Wrenn, Pharma Analyst at GlobalData, comments: “The recent weeks have seen a slight rise in new cases, and though this increase is minimal, if cases continue […]
Immune checkpoint inhibitors will represent 47% of the 5EU gastric and gastroesophageal market by 2029
The lack of approved immune checkpoint inhibitors (ICI) in the gastric and gastroesophageal adenocarcinoma (G/GEJAC) market in the *5EU is expected to significantly enhance the revenue of Opdivo and Keytruda following their upcoming label expansions. In fact, GlobalData’s latest report, ‘Gastric and Gastroesophageal Junction Adenocarcinoma Global Drug Forecast and Market Analysis to 2029’, notes that these […]
The US has the largest number of late-stage COVID-19 vaccines in development
With Pfizer/BioNTech’s COVID-19 vaccine becoming the first mRNA vaccine in the world to receive emergency use approval by the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA), the race is on for other bio/pharma companies with COVID-19 candidates to seek out authorization from regulators within the coming weeks, says GlobalData, a leading data and analytics company. Sharon Cartic at GlobalData comments: “The US has the largest number of COVID-19 vaccines in late-stage clinical development among the top pipeline geographies, with the EU following closely behind. The US currently has a total of 12 COVID-19 vaccines in Phases II and III, […]
Galapagos Phase IIA PINTA IPF topline study results are cause for cautious optimism
Galapagos recently reported positive topline results from its Phase IIA PINTA clinical trial investigating the use of 100 mg GLPG1205 for the treatment of idiopathic pulmonary fibrosis (IPF). Although the trial had a promising result in a disease with high unmet clinical need, the real test for the drug will come in the form of larger trials and subsequent statistical evaluation, according to GlobalData a leading data […]